Understanding the metabolism or efficacy of a candidate drug is crucial in determining whether the drug can be commercialized. Current methods of investigating such drug aspects before entering human studies rely heavily on animal and in vitro models. Thus, when taking drugs into humans for the first time, there is a concern that drug metabolism pathways, effect on target tissues and organs, pharmacokinetics, etc., might differ substantially from those predicted from the model studies. Some of these differences are of no practical consequence, while others are so serious that the development program must be abandoned. Information about efficacy and metabolism is also useful in determining the optimal drug or drug combination to use in treating a given patient.
Given that the results of currently available methods for screening candidate compounds are unpredictable, drug development is a long, complex, and expensive endeavor. Typical development times may be between 10 and 15 years. Furthermore, the cost of developing a newly marketed drug may reach between about one to two billion dollars (Di Masi, J. A. et al. The Price of Innovation: New Estimates of Drug Development Costs. J. Hlth. Econ., Vol. 22: 151-185 (2003)).
In view of the importance of drug development in treating medical conditions, devices having improved predictability would be useful. Devices for obtaining profiles of candidate drug data in humans would be desirable. In particular, devices capable of providing human data on the local effect of a drug candidate on the target tissue or organ would be desirable.